Menstrual disc and methods of use

ABSTRACT

Provided herein are systems, methods and apparatuses for a Menstrual disc.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application and claimspriority to U.S. nonprovisional application Ser. No. 17/320,667, filedMay 14, 2021, which claims priority U.S. provisional application Ser.No. 63/176,685, filed Apr. 19, 2021, all herein incorporated byreference in their entireties.

BACKGROUND

The invention generally relates to reusable feminine hygiene productsand their use in managing menstruation, and more specifically, tofeatures that improve the insertion and removal process, overallcomfort/fit, and capacity/wear time to improve the period experience andreduce environmental waste.

Menstrual Discs are an emerging category in reusable/sustainable periodcare and still somewhat undefined. The reusable period category includesmenstrual cups, menstrual discs, reusable pads and period underwear. Inaddition, there are disposable menstrual discs that fulfill slightlydifferent user needs. Since the category is nascent, there are only afew reusable menstrual discs in market currently and most brands aresold DTC and/or outside of the USA. There is not an established “stateof the art” norm in discs. The disposable discs (produced byFlex/Softdisc) have the longest history in the category, but are notreusable, so do not resonate as strongly with consumers seeking moresustainable period care products

Menstrual cups are more prevalent and there are many brands in-market.However, menstrual cups are also still emerging. That said, menstrualcups have gained traction in the past 4 years and are an entry point tothe reusable products category. Sizing is one of the main pain points inmenstrual cups. There are two main factors in selecting the right sizecup: pelvic floor strength and cervix height. Most women are unaware oftheir own pelvic floor strength and cervix height. Thus, a universallysized disc would solve the sizing problem—and potentially increase theadoption of reusable products.

Lumma, Nixit, and Intimina all have reusable menstrual discs. Becausethe disc sits higher up in the vagina (in the vaginal fornix), manywomen have trouble removing the disc—citing examples of messy removaland/or not being able to get a firm grip on the edge of the disc. OnlyLumma has attempted to innovate removal with the inclusion of a removalstring. In our research, some women find the string toolong/uncomfortable. One of the benefits of a menstrual disc is that itcan remain in place and allow a woman to have sexual intercourse duringher period. Lumma's removal string interfered with this benefit.

Both Nixit and Intimina's products are on the larger range of diameterand intimidating to some women (for insertion). Only Lumma has attemptedsmall, medium and large sizing of the menstrual disc to address femaleanatomy. The diaphragm has a different purpose than the menstrual disc(preventing pregnancy versus collecting menses) but anatomically, sitsin the same place in a woman's body, in the vaginal fornix.

In testing Nixit and Intimina, insertion was difficult. Intimina's softrim made the disc flexible and easy to fold—but once inside the vagina,it was very difficult to open in the vaginal fornix and orient properly.Nixit's firm rim was easier to guide into place, but their thicker catchmade the product uncomfortable once inserted.

The present invention attempts to solve these problems as well asothers.

SUMMARY OF THE INVENTION

Provided herein are systems, methods and apparatuses for a Menstrualdisc. In one embodiment, the Menstrual disc comprises an inner rimoperably connected with a pull tab and a central catch portion, whereinthe inner rim and the pull tab form a generally C-shape opening; thecentral catch portion operably connected with an outer rim including atleast one grip portion and a curved top portion; wherein the outer rimis a semi-firm compliant rim that operates to fold inward towards anaxis of the Menstrual disc to conform to a folded configuration from anopen configuration; the axis runs from a front portion of the Menstrualdisc to a back portion; the at least one grip portion is positionedperpendicular to the axis to permit folding of the Menstrual discinwards towards the axis; and the central catch portion is operable tocontain a menstrual fluid.

In one embodiment, a method of using a Menstrual disc comprises: foldingthe Menstrual disc to a folded configuration to a diameter D2 from adiameter D1 from an open configuration, wherein the diameter D2 of thefolded configuration is between about 15 mm and about 35 mm; insertingthe diameter D2 of the folded configuration through the vagina; tuckinga front rim of the Menstrual disc up and behind the pubic bone toposition the Menstrual disc; unfolding the Menstrual disc to the openconfiguration once the Menstrual disc is under the cervix; tucking a toprim portion of the Menstrual disc under the pubic bone such that theMenstrual Disc sits within the fornix without a seal; and collectingmenstrual fluid with the Menstrual disc during a menstrual period.

The methods, systems, and apparatuses are set forth in part in thedescription which follows, and in part will be obvious from thedescription, or can be learned by practice of the methods, apparatuses,and systems. The advantages of the methods, apparatuses, and systemswill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the methods, apparatuses, and systems, as claimed.

Accordingly, it is an object of the invention not to encompass withinthe invention any previously known product, process of making theproduct, or method of using the product such that Applicants reserve theright and hereby disclose a disclaimer of any previously known product,process, or method. It is further noted that the invention does notintend to encompass within the scope of the invention any product,process, or making of the product or method of using the product, whichdoes not meet the written description and enablement requirements of theUSPTO (35 U.S.C. § 112, first paragraph) or the EPO (Article 83 of theEPC), such that Applicants reserve the right and hereby disclose adisclaimer of any previously described product, process of making theproduct, or method of using the product. It may be advantageous in thepractice of the invention to be in compliance with Art. 53(c) EPC andRule 28(b) and (c) EPC. All rights to explicitly disclaim anyembodiments that are the subject of any granted patent(s) of applicantin the lineage of this application or in any other lineage or in anyprior filed application of any third party is explicitly reserved.Nothing herein is to be construed as a promise.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying figures, like elements are identified by likereference numerals among the several preferred embodiments of thepresent invention.

FIG. 1 is a perspective view of the Menstrual disc, according to oneembodiment.

FIG. 2 is a side view of the Menstrual disc showing the grip portion,according to one embodiment.

FIG. 3 is a top view of the Menstrual disc, according to one embodiment.

FIG. 4 is a front view of the Menstrual disc showing the pull tab,according to one embodiment.

FIG. 5 is a cross-sectional view of the Menstrual disc taken along lines5-5 from FIG. 4, according to one embodiment.

FIG. 6 is a bottom perspective view showing the Menstrual disc and thepull tab, according to one embodiment.

FIG. 7 is a back view of the Menstrual disc, according to oneembodiment.

FIG. 8 is a side view of the Menstrual disc showing the grip portion,according to one embodiment.

FIG. 9 is a cross-sectional view of the Menstrual disc taken along lines9-9 from FIG. 8, according to one embodiment.

FIG. 10 is a bottom view of the Menstrual disc showing the pull tab,according to one embodiment.

FIG. 11 is a depiction of the Menstrual disc disposed in the foldedconfiguration, according to one embodiment.

FIG. 12 is a schematic display of the cervix and fornix anatomy wherethe Menstrual disc is operably disposed.

DETAILED DESCRIPTION OF THE INVENTION

The foregoing and other features and advantages of the invention areapparent from the following detailed description of exemplaryembodiments, read in conjunction with the accompanying drawings. Thedetailed description and drawings are merely illustrative of theinvention rather than limiting, the scope of the invention being definedby the appended claims and equivalents thereof.

Embodiments of the invention will now be described with reference to theFigures, wherein like numerals reflect like elements throughout. Theterminology used in the description presented herein is not intended tobe interpreted in any limited or restrictive way, simply because it isbeing utilized in conjunction with detailed description of certainspecific embodiments of the invention. Furthermore, embodiments of theinvention may include several novel features, no single one of which issolely responsible for its desirable attributes or which is essential topracticing the invention described herein.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention are to be construed to cover boththe singular and the plural, unless otherwise indicated herein orclearly contradicted by context. It will be further understood that theterms “comprises,” “comprising,” “includes,” and/or “including,” whenused herein, specify the presence of stated features, integers, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, integers, steps,operations, elements, components, and/or groups thereof.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. The word “about,” when accompanying anumerical value, is to be construed as indicating a deviation of up toand inclusive of 10% from the stated numerical value. The use of any andall examples, or exemplary language (“e.g.” or “such as”) providedherein, is intended merely to better illuminate the invention and doesnot pose a limitation on the scope of the invention unless otherwiseclaimed. No language in the specification should be construed asindicating any nonclaimed element as essential to the practice of theinvention.

References to “one embodiment,” “an embodiment,” “example embodiment,”“various embodiments,” etc., may indicate that the embodiment(s) of theinvention so described may include a particular feature, structure, orcharacteristic, but not every embodiment necessarily includes theparticular feature, structure, or characteristic. Further, repeated useof the phrase “in one embodiment,” or “in an exemplary embodiment,” donot necessarily refer to the same embodiment, although they may.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts. Unless otherwise expressly stated, it isin no way intended that any method or aspect set forth herein beconstrued as requiring that its steps be performed in a specific order.Accordingly, where a method claim does not specifically state in theclaims or descriptions that the steps are to be limited to a specificorder, it is no way intended that an order be inferred, in any respect.This holds for any possible non-express basis for interpretation,including matters of logic with respect to arrangement of steps oroperational flow, plain meaning derived from grammatical organization orpunctuation, or the number or type of aspects described in thespecification.

Generally speaking, the Menstrual disc is a reusable feminine hygieneproduct and the method of using the Menstrual disc is for managingmenstruation, and more specifically, to features that improve theinsertion and removal process, overall comfort/fit, and capacity/weartime to improve the period experience and reduce environmental waste.

The Menstrual disc is a simple, reusable alternative to pads and tamponsdesigned to fit most women and stay in place comfortably. The Menstrualdisc comprises a finger-width groove on the underside of the rim with atextured surface to improve grip, wherein the finger-width groove allowsa user to easily hook their finger on the underside on the disc. Thisfinger-width groove provides a method for emptying the Menstrual discduring wear without removal of the Menstrual disc from the vagina.Alternatively, the method provides for the emptying the Menstrual discwith removal of the Menstrual disc from the vagina, and reuse aftercleaning and sanitizing.

The Menstrual disc comprises a diameter and a rim height specificallyselected based on the anatomical features of the female body. Pelvicfloor strength (influenced by age, childbirth, and weight, among otherfactors), cervix height (varies during the menstrual cycle) and fluidcapacity are all size, property, and dimension considerations for theMenstrual disc. The diameter contribute to proper fit/comfort anduniversal sizing for most women, while the rim height and diameter arerelated to the capacity of the Menstrual disc. The diameter and rimheight provide a fluid capacity to hold between about 30 ml to about 50ml, alternatively about 47.5 mL of menstrual fluid for a comparativelylong wear time up to about 12 hours. The Menstrual disc comprises therim height with a thin catch, a side rim finger grip that provides themethod of the folding and inserting the Menstrual disc through thevagina toward and contacting the cervix, and disposing the Menstrualdisc within the fornix.

As shown in FIG. 1, the Menstrual disc 100 is a generally circularconfiguration and comprises an inner rim 110 operably connected with apull tab 120 and a central catch portion 130. The central catch portion130 is operably connected with an outer rim 140 including at least onegrip portion 142 and a curved top portion 144, as shown in FIG. 2. Theouter rim 140 is a semi-firm compliant rim or semi-resilient orsemi-elastic rim that operates to fold inward towards an axis 102 of theMenstrual disc to conform to a folded configuration from an openconfiguration, as shown in FIG. 1. The axis 102 runs from a frontportion of the Menstrual disc 100 to a back portion and willsubstantially align with the sagittal plane of the human body when theMenstrual disc 100 is removably implanted or temporarily installedwithin vagina. The at least one grip portion 142 allows a user to foldthe Menstrual disc along the axis 102 to the folded configuration andthe grip portion 142 minimizes slippage during folding and insertion.The at least one grip portion 142 is positioned perpendicular to theaxis 102 to permit folding of the Menstrual disc inwards towards axis102. The at least one grip portion 142 includes a frictional componentto allow a user to grip and fold the Menstrual disc into the foldedconfiguration and insert the Menstrual disc without the user losing gripon the Menstrual disc. The folded configuration is operable for a userto insert the Menstrual disc and the open configuration is operable tocover the cervix within the fornix. The cervix projects into the vagina,and the circular trough formed at the upper end of the vagina around thecervix is the fornix. When removably implanted in the openconfiguration, the Menstrual disc 100 sits at an angle A1 off itslongitudinal axis 104, as shown in FIG. 12. The central catch portion130 is operable to contain, catch, or maintain menstrual fluid during amenstrual period and optimizes comfort for the user. The top portion ofthe pull tab 120 is operably connected to the top portion of the outerrim 140 to generate a non-annular opening or a generally C-shape openingof the Menstrual disc 100 in the open configuration.

As shown in FIG. 3, the Menstrual disc 100 and the curved top portion144 includes a diameter D1, the upper rim 110 includes a rim height H1,and the Menstrual disc 100 includes a disc height H2, as shown in FIG.4. In one embodiment, the diameter D1 is between about 60 mm and 70 mm,alternatively, between about 62 mm and about 68 mm, alternativelybetween about 64 mm and about 66 mm, alternatively about 65 mm. In oneembodiment, the rim height H1 is between about 9 mm and about 14 mm,alternatively, between about 10 mm and about 13 mm, alternatively,between about 11 mm and about 12 mm, alternatively about 11 mm. The discheight H2 is between about 28 mm and about 35 mm, alternatively, betweenabout 29 mm and about 34 mm, alternatively, between about 30 mm and 33mm, alternatively, about 31 mm. The curved top portion 144 includes aradius of curvature, as shown in FIG. 5. The radius of curvature betweenabout 4 mm and about 8 mm, alternatively, between about 5 mm and about 7mm, alternatively, about 6 mm. The radius of curvature is sized topermit smooth insertion of the Menstrual disc through the vagina openingand the cervix.

The upper rim 110 and the outer rim 140 include a rim thickness R1, asshown in FIG. 5. In one embodiment, R1 is between about 5.0 mm and about6.0 mm, alternatively, between about 5.1 mm and about 5.9 mm,alternatively, between about 5.2 mm and about 5.8 mm, alternativelyabout 5.75 mm. In one embodiment, the ratio of the rim height H1 and rimthickness R1 is between about 0.9 and about 2.9, alternatively the ratioof H1:R1 is between about 1.2 and about 2.7, alternatively, betweenabout 1.5 and about 2.5, alternatively, between about 1.7 and about 2.2,alternatively, about 1.83, alternatively, about 1.91. In one embodiment,the ratio of rim height H1 to rim thickness R1 is less than 2. The ratioof rim height H1 to rim thickness R1 is sized to provide optimal foldingcapability of the Cora Disc while permitting the rim to sit against thefornix during operation. The rim height H1 relates to the capacity ofthe disc; the rim thickness R1 relates to the firmness, which allows foran easier insertion experience and allows the user to get the disc inplace more easily.

The pull tab 120 includes a rim portion 122, an underside groove 124,and a sloped portion 126, as shown in FIG. 3. The rim portion 122operably couples with the curved top portion 144 of the outer rim 140 tocreate the non-annular or generally C-shape opening of the MenstrualDisc 100. The rim portion 122 of the pull tab 120 provides additionalstructural support for the outer rim 140 when the Menstrual disc is inthe open configuration and temporarily implanted. The underside groove124 includes a width U1, as shown in FIG. 3, and a depth U2, as shown inFIG. 5. The width U1 and the depth U2 is a groove sized to permit a userto locate the Menstrual disc within the vagina and sized for the user'sfinger to grip the pull tab 120 and withdraw the Menstrual disc from thevagina. The width U1 and the depth U2 is also the approximate width anddepth of the rim portion 122 of the pull tab 122. The width and depth ofthe rim portion 122 contributes to the structural support of theMenstrual disc in the open configuration when temporarily implanted. Inone embodiment, the underside groove 124 includes a textured surface126, as shown in FIGS. 6 and 10, to permit a user's fingertip to gripthe pull tab 120 sufficiently within the vagina. The textured surface126 includes a plurality of tabs designed with a raised geometriccomponent to permit a user to grip the underside groove 124 when wet orcovered by a fluid or menstrual fluid. In one embodiment, the raisedgeometric component includes a polygonal or quadrilateral profile. Thepull tab 120 is oriented closest to the vaginal opening and the rimportion 122 along with the underside groove 124 allows the user to tiltthe Menstrual disc in an upright position to avoid spilling menstrualfluid during removal of the Menstrual disc from the vagina. In oneembodiment, width U1 and depth U2 are between about 9 mm and about 15mm, alternatively, between about 10 mm and about 14 mm, alternativelyabout 11 m. The sloped portion 126 includes a width S1 between about 0.5mm and about 1.5 mm, alternatively, between about 0.7 mm and about 1.2mm, alternatively between about 0.9 and 1.1 mm. The sloped portion 126is sized to operably connect with the central catch portion 130. Thewidth S1 is sized to be greater than the thickness of the central catchportion 130, to permit greater stiffness when the pull tab 120 is pulledaway from an axis of the Menstrual disc and allow menstrual fluiddisposed in the central catch portion 130 to be disposed from theMenstrual disc when the pull tab 120 is engaged by a user. The rimportion 122 includes a triangular thickness profile, as shown in FIG. 5.The triangular thickness profile allows for the semi-rim stiffness ofthe outer rim 140 on the top portion of the Menstrual disc, whileallowing for a thinner thickness on the bottom portion of the rimportion 122 to permit a user to deflect or grab the rim portion 122 ofthe pull tab 120. Each of the pull tab 120, underside groove 124, ortextured surface 126 may be independently modified, sited, or shapeddifferently to meet the needs of the user, menstrual fluid, or anatomy.

As shown in FIG. 5, the central catch portion 130 includes a catchheight C1 and a catch capacity. In one embodiment, the catch capacity isbetween about 35 ml and about 50 ml, alternatively, between about 46 mland 48 ml, alternatively, about 47.5 ml. The central catch portion 130sits flat within the vaginal canal. And the catch capacity is the volumeof a cylinder (Π r{circumflex over ( )}2h). The volume of a cylindercalculation is used for the catch capacity of the Menstrual disc whennot fully open once inserted into the vagina. The central catch portion130 includes a catch thickness C2, as shown in FIG. 5. The catchthickness C2 is sized to permit the central catch portion 130 to restcomfortably within the vagina, allow the Menstrual disc to fold to thefolded configuration, and secure when menstrual fluid is disposed withinthe central catch portion 130. In one embodiment, the catch thickness C2is between about 0.1 mm and about 0.7 mm, alternatively, between about0.2 mm and about 0.6 mm, alternatively, between about 0.3 mm and about0.5 mm, alternatively, about 0.4 mm. The catch thickness C2 expands to arim thickness C3 when the central catch portion 130 connects with theouter rim 140. In one embodiment, C3 is between about 0.8 mm and about1.2 mm, alternatively, between about 0.9 mm and 1.1 mm, alternativelyabout 1.0 mm.

FIG. 8 is a side view of the Menstrual disc 100 showing the grip portion142, according to one embodiment. The grip portion 142 is comprised ofat least two concentric circles that may be indentations on the outerrim 140 or raised portions on the outer rim 140 to provide the grippingaction to flex the Menstrual disc to the folded configuration. The atleast two concentric circles may be overlapping or may be separated by adistance. The at least two concentric circles may include smallerconcentric circles within a larger concentric circle to provideadditional gripping portions. The diameter of the concentric circles mayinclude a diameter approximating the tip of finger. In one embodiment,the concentric circles include at least 2 smaller concentric circlesconfined with a larger concentric circle.

FIGS. 7 and 9 show that the outer rim 140 comprises an outer lip 148disposed around the outer surface of the outer rim 140 and between theouter surface of the central catch 130. The outer lip 148 provides aseated surface in which to dispose the Menstrual disc on the fornix. Theouter lip 148 may include a seated surface between about 0.1 mm andabout 3.0 mm, alternatively between about 0.5 mm and 2.5 mm,alternatively, between about 0.9 mm and 2.0 mm. The semi-firm complianceof the outer rim 140 ensures the outer lip 148 and the seated surfacemaintain appropriate stiffness when the Menstrual disc is disposed onthe fornix and when the central catch 130 includes menstrual fluiddisposed therein.

In operation, the Menstrual disc is folded to the folded configurationand includes a diameter D2, as shown in FIG. 11. In one embodiment, thefolded configuration is a generally FIG. 8 configuration. The diameterD2 of the folded configuration is between about 15 mm and about 35 mm,alternatively, between about 20 mm and about 30 mm. The diameter D2 ofthe folded configuration permits the Menstrual disc to be insertedthrough the vagina, as shown in FIG. 12. The user guides the back rim ofthe Menstrual disc into the vagina and tucks the front rim up and behindthe pubic bone to position the Menstrual disc. Once the user is underthe cervix, the Menstrual disc is unfolded to the open, semi-hemisphericconfiguration, where the top rim portion tucks under the pubic bone andsits in the fornix without requiring suction. Cervix height is thedistance from the vaginal opening to the cervix and the cervix height ison average between about 3 and about 4 inches and varies to less than 3and up to about 5 inches. In one embodiment, the Menstrual disc sitshigher in the vaginal canal and rests within the fornix to receive orcatch menstrual fluid during a menstrual period. When removablyimplanted or temporarily installed in the open configuration, theMenstrual disc 100 sits at an angle A1 off its longitudinal axis 104 andthe axis 102 which sits on the sagittal plane at the base of posteriorcervix, as shown in FIG. 12. In one embodiment, the open configurationof the Menstrual disc when removably implanted is a smaller openconfiguration due to the top rim portion being bent inward. TheMenstrual disc may collect fluid for an extended period of time up toabout 12 hours when disposed on the fornix. The Menstrual disc may emptya fluid while the Menstrual disc is disposed within the fornix by theuser gripping the pull tab and tilting the pull tab downwards towardsthe vaginal opening to remove the fluid. The underside groove of thepull tab aids in the removal process by allowing a user to easily hooktheir finger on the underside on the Menstrual disc and the user gentlyslides the Menstrual disc out of the vagina.

In one embodiment, the Menstrual disc is made from medical gradesilicone, polymer, rubber, or other elastomeric or biocompatiblematerial. The menstrual disc is intended to be washable and reusable.

In an alternative embodiment, the Menstrual disc may be used for stressincontinence. The placement of the Menstrual disc inside the vagina putsgentle pressure on the bladder and could function similar to a pessary.A pessary is a prosthetic device that can be inserted into the vagina tosupport its internal structure. It's often used in the case of urinaryincontinence and a vaginal or pelvic organ prolapse. The Menstrual disccould catch urine or other fluids. The Menstrual disc may also be usedas a specimen collector to collect blood and/or vaginal, cervical and/oruterine discharge, including for diagnostic purposes.

The Menstrual disc is not limited to the preferred embodiments describedherein. For example, the Menstrual disc is not restricted to human use.The Menstrual disc may be used to collect discharge from non-humanprimates and other animals, and/or for substance delivery for veterinaryapplications. For non-human primate and other veterinary uses, thedimensions of the devices would be sized or adapted to fit thedimensions of the vaginal canal of the animal concerned.

EXAMPLES

The following examples are put forth so as to provide those of ordinaryskill in the art with a complete disclosure and description of how thecompounds, compositions, articles, devices and/or methods claimed hereinare made and evaluated, and are intended to be purely exemplary of theinvention and are not intended to limit the scope of what the inventorsregard as their invention. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention.

Efforts have been made to ensure accuracy with respect to numbers (e.g.,amounts, temperature, etc.), but some errors and deviations should beaccounted for. Unless indicated otherwise, parts are parts by weight,temperature is in ° C. or is at ambient temperature, and pressure is ator near atmospheric.

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

While the invention has been described in connection with variousembodiments, it will be understood that the invention is capable offurther modifications. This application is intended to cover anyvariations, uses or adaptations of the invention following, in general,the principles of the invention, and including such departures from thepresent disclosure as, within the known and customary practice withinthe art to which the invention pertains.

What is claimed is:
 1. A Menstrual disc, comprising: an inner rimoperably connected with a pull tab and a central catch portion, whereinthe inner rim and the pull tab form a generally C-shape opening; thecentral catch portion operably connected with an outer rim including atleast one grip portion and a curved top portion; wherein the outer rimis a semi-firm compliant rim that operates to fold inward towards anaxis of the Menstrual disc to conform to a folded configuration from anopen configuration; the axis runs from a front portion of the Menstrualdisc to a back portion; the at least one grip portion is positionedperpendicular to the axis to permit folding of the Menstrual discinwards towards the axis; and the central catch portion is operable tocontain a menstrual fluid.
 2. The Menstrual disc of claim 1, wherein theouter rim include a rim thickness R1 and a rim height H1, and the ratioof the rim height H1 and rim thickness R1 is between about 0.9 and about2.0.
 3. The Menstrual disc of claim 1, wherein the outer rim include arim thickness R1 and a rim height H1, and the ratio of the rim height H1and rim thickness R1 is about 1.83.
 4. The Menstrual disc of claim 2,wherein the R1 is between about 5.0 mm and about 6.0 mm.
 5. TheMenstrual disc of claim 3, wherein the Menstrual disc includes adiameter D1, and the Menstrual disc includes a disc height H2, whereinthe diameter D1 is between about 60 mm and 70 mm, the rim height H1 isbetween about 9 mm and about 14 mm, and the disc height H2 is betweenabout 28 mm and about 35 mm.
 6. The Menstrual disc of claim 1, whereinthe pull tab includes a rim portion, an underside groove, and a slopedportion; the underside groove includes a width U1 and a depth U2,wherein the width U1 and the depth U2 is a groove sized to permit a userto grip the pull tab and withdraw the Menstrual disc from the vagina;the underside groove includes a textured surface.
 7. The Menstrual discof claim 6, wherein the textured surface includes a plurality of tabsdesigned with a raised geometric component.
 8. The Menstrual disc ofclaim 6, wherein the width U1 and the depth U2 are between about 9 mmand about 15 mm; the sloped portion includes a width S1 between about0.5 mm and about 1.5 mm, the width S1 is greater than a thickness of thecentral catch portion
 9. The Menstrual disc of claim 8, wherein the rimportion includes a triangular thickness profile; the outer rim includesa semi-rim stiffness and a thinner thickness on a bottom portion of therim portion.
 10. The Menstrual disc of claim 9, wherein the centralcatch portion includes a catch height C1 and a catch capacity; whereinthe catch capacity is between about 35 ml and about 50 ml when thecentral catch portion sits within the vaginal canal; and the centralcatch portion includes a catch thickness C2 between about 0.1 mm andabout 0.7 mm; the catch thickness C2 expands to a rim thickness C3 whenthe central catch portion connects with the outer rim; wherein the rimthickness C3 is between about 0.8 mm and about 1.2 mm.
 11. The Menstrualdisc of claim 9, wherein the grip portion comprises at least twoconcentric circles.
 12. The Menstrual disc of claim 11, wherein theouter rim comprises an outer lip disposed around the outer surface ofthe outer rim and between the outer surface of the central catch.
 13. Amethod of using a Menstrual disc, comprising: folding the Menstrual discto a folded configuration to a diameter D2 from a diameter D1 from anopen configuration, wherein the diameter D2 of the folded configurationis between about 15 mm and about 35 mm; inserting the diameter D2 of thefolded configuration through the vagina; tucking a front rim of theMenstrual disc up and behind the pubic bone to position the Menstrualdisc; unfolding the Menstrual disc to the open configuration once theMenstrual disc is under the cervix; resting a top rim portion of theMenstrual disc within the fornix and the Menstrual Disc sits within thefornix without a seal; and collecting menstrual fluid with the Menstrualdisc during a menstrual period.
 14. The method of claim 13, wherein thetop rim portion include a rim thickness R1 and a rim height H1, and theratio of the rim height H1 and rim thickness R1 is between about 0.9 andabout 2.0.
 15. The method of claim 13, collecting menstrual fluid for atime period up to about 12 hours.
 16. The method of claim 13, furthercomprising emptying the menstrual fluid while the Menstrual disc isdisposed within the fornix by the user gripping a pull tab and tiltingthe pull tab downwards towards the vaginal opening to remove themenstrual fluid.
 17. The method of claim 13, further comprising removingthe Menstrual disc from the vagina with an underside groove of theMenstrual Disc by allowing a user to hook their finger on an undersideon the Menstrual disc and sliding the Menstrual disc out of the vagina.18. The method of claim 13, wherein the folded configuration is agenerally FIG. 8 configuration.